A Multidisciplinary Weight Loss Program at AUB-MC

Obesity Clinical Trial

Official title:

A Multidisciplinary Weight Loss Program at AUB-MC: An Open Label Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04194424
• Other study ID #: BIO-2018-0400
• Status: Recruiting
• Phase: N/A
• Start date: June 17, 2019
• Est. completion date: December 2023

Study information

• Verified date: August 2022
• Source: American University of Beirut Medical Center
• Contact: Marlene Chakhtoura, MD, MSc
• Phone: +9611350000
• Email: mc39[@]aub.edu.lb
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The current project aims at evaluating the feasibility and efficacy of a multi-disciplinary weight loss program, using an innovative and simple dietary intervention at the American University of Beirut Medical Center (AUB-MC). Such intervention is expected to enhance patients' compliance and adherence to lifestyle changes. In addition, the program includes supervised exercise sessions and behavioral therapy. Therefore, our project proposes an evidence based approach to close the obesity treatment gaps.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Lebanese adult with obesity (=18 years), obesity being defined as BMI = 30 kg/m2
• Patients who can commit to frequent visit trials as per study protocol
• Patients not traveling outside Lebanon for at least the 6-month period of the trial
• Patients tolerating Metformin after a run-in period of 2 weeks

Exclusion Criteria:

• Patients who have taken other weight reducing drug therapy in the previous 6 months
• Patients who have undergone bariatric therapy or endoscopic procedure, or planning to do so in the near future (at < 6 months)
• Patients with diabetes
• Patients working at AUB-MC, as we will not be able to assess the adherence to study visits nor the feasibility of such a program in the general population, presenting to AUB-MC only for clinical care
• A family member of a patient already enrolled in the study, as the participants will not be independent
• Pregnant obese patients
• Patients with pacemakers
• Patients known to have hypertension, cardiac, pulmonary, renal or liver disease, active cancer or psychiatric illnesses
• History of any surgery of less than 6 weeks duration
• Patients known to have disabling osteoarthritic or orthopedic problems
• Patients secondary uncontrolled endocrine disorders (thyroid disorders, polycystic ovary, Cushing disease), or drug induced obesity (such as anti-psychotic, steroids, hormonal therapy).

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Weight Loss

Intervention

Other:
• Multidisciplinary weight loss program
Diet and behavioral therapy,and supervised exercise sessions
• Standard Care
General lifestyle tips

Drug:
• Metformin Hcl 850Mg Tab
1 tablet, twice daily

Locations

Country	Name	City	State
Lebanon	American University of Beirut - Medical Center	Beirut	Riad El Solh

Sponsors (1)

Lead Sponsor	Collaborator
American University of Beirut Medical Center

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in weight	TANITA Body Composition (BC) 418 MA Segmental Body Composition Analyzer will measure Weight in kg	6 months after enrollment
Other	Change in BMI	TANITA BC 418 MA Segmental Body Composition Analyzer will measure BMI (kg/m^2) by combining the height and weight.	6 months after enrollment
Other	Change in body composition	TANITA BC 418 MA Segmental Body Composition Analyzer will measure total body measurements for: Fat Mass, Fat Free Mass, Total Body Water (in kg)	6 months after enrollment
Other	basal metabolic rate (BMR)	TANITA BC 418 MA Segmental Body Composition Analyzer will measure BMR	6 months after enrollment
Other	Change in physical fitness (distance)	Physical fitness will be assessed using the 6 minute walk test. Measure to be collected at beginning and end of test is: distance covered in meters	6 months after enrollment
Other	Change in resting blood pressure before and after physical exercise	Physical fitness will be assessed using the 6 minute walk test. Measure to be collected at beginning and end of test is: resting blood pressure	6 months after enrollment
Other	Change in oxygen saturation before and after physical exercise	Physical fitness will be assessed using the 6 minute walk test. Measure to be collected at beginning and end of test is: oxygen saturation	6 months after enrollment
Other	Change in heart rate before and after physical exercise	Physical fitness will be assessed using the 6 minute walk test. Measure to be collected at beginning and end of test is: heart rate.	6 months after enrollment
Other	Change in physical fitness (Perceived Exertion)	Physical fitness will be assessed using the 6 minute walk test. Rated Perceived Exertion (RPE) scale score will be administered.	6 months after enrollment
Other	Change in levels of appetite hormones and metabolic markers	At visit 3 and completion visit (visit 5), blood samples will be withdrawn for various hormones and proteins related to appetite and satiety including Gastric inhibitory polypeptide (GIP), Leptin, Glucagon like peptide 1 (GLP1), Irisin, Insulin, Ghrelin, Orexin, IL6; These samples will be processed and preserved in the Calcium Metabolism and Osteoporosis Program lab in our institution, and the tests will be run later on, when additional funds are available.	6 months after enrollment
Other	Change in levels of Mineral markers and hormones (cross laps)	At visit 3 and completion visit (visit 5), blood samples will be withdrawn for various mineral markers and hormones including Crosslaps (pg/mL).; These samples will be processed and preserved in the Calcium Metabolism and Osteoporosis Program lab in our institution, and the tests will be run later on, when additional funds are available.	6 months after enrollment
Other	Change in levels of Mineral markers and hormones (Osteocalcin)	At visit 3 and completion visit (visit 5), blood samples will be withdrawn for various mineral markers and hormones including Osteocalcin (ng/mL).; These samples will be processed and preserved in the Calcium Metabolism and Osteoporosis Program lab in our institution, and the tests will be run later on, when additional funds are available.	6 months after enrollment
Other	Participants' compliance	Adherence to the dietary intervention: [Number of days the dieticians are contacted/ Total number of days] X 100 Adherence to program visits: [Number of visits attended/ Total number of visits] X 100	6 months after enrollment
Primary	Mean percent weight loss per treatment arm	[(baseline weight-follow up weight at 6 months)/ baseline weight] X 100	6 months after enrollment